METOPROLOL TARTRATE Recall D-0362-2022
Description: Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00
METOPROLOL TARTRATE Recall D-0362-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0362-2022 |
| Event ID | 89311 |
| Brand | METOPROLOL TARTRATE |
| Generic Name | METOPROLOL TARTRATE |
| Manufacturer | METOPROLOL TARTRATE |
| Original Package? | 1 |
| Active Substance | METOPROLOL TARTRATE |
| Drug Route | ORAL |
| Distribution | Product was distributed to one distributor who may have distributed the product further nationwide. |
| Quantity | 3,684 1000-count bottles |
| Recall Reason | Complaint received of foreign matter (metal) embedded in tablet. |
| Drug Classification | Class II |
| Drug Code Info | 20220119 |
| Product NDC | 52817-358 52817-362 52817-359 |
| Drug UPC | 0352817358103 0352817362100 0352817362001 |
| Recall Initiation Date | 20211231 |
| Report Date | 20220119 |
| Classification Date | 20220107 |
| Address | 4 & K 30 5 Plot No K 30 Ambernath, India |
| Recalling Firm | Rubicon Research Private Limited |
| Initial Notification | Letter |
| Unique Ingredient Identifier | W5S57Y3A5L |
| Drug Application Number | ANDA200981 |
| Structured Product Labeling (SPL ID) | be1b1011-ee45-331c-e053-2995a90ae2fd |
| Structured Product Labeling (SPL Set ID) | 52c822f2-4a71-4ab2-a470-58074622846a |
| Similar To |